FDA Permits New Sunscreen Ingredient After 20 Years - Summary - MDSpire

FDA Permits New Sunscreen Ingredient After 20 Years

The sunscreen ingredient, which has been marketed internationally for years, is considered generally recognized as safe and effective for use in adults and pediatric patients aged 6 months and older.

  • By

  • Kathryn Wighton

  • June 9, 2026

  • 2 min

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Objective:

To announce the addition of bemotrizinol to the OTC sunscreen monograph.

Key Findings:
  • Bemotrizinol provides protection against both UVA and UVB radiation, as stated by the FDA.
  • It has low systemic absorption following topical use, according to the FDA.
  • The ingredient has been marketed in Europe and other countries prior to U.S. authorization, as noted by the FDA.
Interpretation:

Limitations:
  • The FDA's action does not approve any specific sunscreen product containing bemotrizinol.
Conclusion:

Original Source(s)

FDA Permits New Sunscreen Ingredient After 20 Years

  • by Kathryn Wighton

  • June 9, 2026

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